(23 days)
The indications for use for the 3-Piece Proximal Humeral Replacement System include noninflamatory degenerative joint disease including osteoarthritis and avascular necrosis, theumatoid arthritis, correction of severe functional deformity, revision procedures where other treatments or devices have failed, treatment of acute fractures with humeral head involvement which are unmanageable using other treatment methods and oncology applications.
The 3-Piece Proximal Humeral Replacement System is for use with bone cement.
The 3-piece Proximal Humeral Replacement System is a total shoulder prosthesis humeral component in cases where there has been severe proximal bone loss due to a tumor, trauma, or previous device placement.
The modified proximal humeral replacement device can be a combination of a proximal body and stem or proximal body, segment, and stem. The device is designed so that the distal portion of the stem is cemented into the remaining humeral bone with the stem collar, segment, and proximal body residing above the natural bone.
The provided text is a 510(k) summary for a medical device called the "3-piece Proximal Humeral Replacement System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance criteria through clinical trials in the way artificial intelligence (AI) or diagnostic devices typically do.
Therefore, many of the requested categories for AI/diagnostic device studies are not applicable to this 510(k) submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: For a 510(k) submission of this type (proximal humeral replacement system), the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device. This is typically achieved by showing that the new device has the same intended use, technological characteristics (materials, design, sizing), and performs as safely and effectively as the predicate device.
- Reported Device Performance: The primary "performance" reported is related to mechanical testing and the assertion that the device's characteristics are similar or identical to the predicate.
| Acceptance Criterion (Primary for 510(k)) | Reported Device Performance (as stated in submission) |
|---|---|
| Substantial Equivalence to Predicate | "The 3-piece Proximal Humeral Replacement System components—the materials, design, sizing, and indications are similar or identical to the predicate devices." |
| Mechanical Testing Sufficiency | "Mechanical Testing with Engineering Justifications determined that the 3-piece Proximal Humeral Replacement to the predicate device presented no new questions of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- N/A. This submission did not involve a clinical "test set" in the context of an AI or diagnostic device study. The substantial equivalence was based on design, materials, and mechanical testing, not on clinical performance data from a specific patient cohort. The "test set" for mechanical testing would refer to the number of devices mechanically tested, but this detail is not provided in the summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- N/A. As no clinical test set requiring ground truth was presented, no experts were needed for this purpose.
4. Adjudication Method for the Test Set
- N/A. No clinical test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is not an AI or diagnostic device; therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
- N/A. This is a physical orthopedic implant, not an algorithm.
7. The type of ground truth used
- N/A. No ground truth in the context of clinical performance was established for the 510(k) submission. The "ground truth" for substantial equivalence was based on the known, legally marketed predicate device's characteristics and performance, and the mechanical testing of the new device showing similar safety and effectiveness.
8. The sample size for the training set
- N/A. This refers to AI algorithms, which is not applicable here.
9. How the ground truth for the training set was established
- N/A. Not applicable.
Summary of the Study (as described in the 510(k) submission):
The study supporting this 510(k) submission primarily consisted of:
- Comparison to a Predicate Device: The manufacturer demonstrated that the new 3-piece Proximal Humeral Replacement System is "substantially equivalent" to an existing, legally marketed device (the "Proximal Humeral Replacement System," K925613). This involved showing that the new device has similar or identical materials, design, sizing, and indications for use.
- Non-Clinical Mechanical Testing: Mechanical testing with engineering justifications was performed. The conclusion was that this testing "presented no new questions of safety or effectiveness" compared to the predicate device.
- No Clinical Testing: The submission explicitly states, "No clinical testing was provided as a basis for substantial equivalence." This is common for 510(k)s where substantial equivalence can be demonstrated through non-clinical means and comparison to a well-established predicate device.
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JAN 3 0 2002 UARTERS CORPORATE
SUMMARY OF SAFETY AND EFFECTIVENESS
| Applicant or Sponsor: | Biomet Orthopedics, Inc.56 East Bell DriveWarsaw, IN 46581-0587 |
|---|---|
| Contact Person: | Dalene T. BinkleyTelephone: (219) 267-6639 |
| Proprietary Name: | 3-piece Proximal Humeral Replacement System |
| Common Name: | Shoulder prosthesis |
Classification: Prosthesis, shoulder, non-constrained, metal/polymer cemented (21 CFR 888.3650)
Device Classification: Class II
Legally Marketed Device to which Substantially Equivalence is Claimed: The 3piece Proximal Humeral Replacement System has been developed by modifying the Proximal Humeral Replacement System (K925613).
Device Description: The 3-piece Proximal Humeral Replacement System is a total shoulder prosthesis humeral component in cases where there has been severe proximal bone loss due to a tumor, trauma, or previous device placement.
The modified proximal humeral replacement device can be a combination of a proximal body and stem or proximal body, segment, and stem. The device is designed so that the distal portion of the stem is cemented into the remaining humeral bone with the stem collar, segment, and proximal body residing above the natural bone.
Indications for Use: The indications for use for the 3-Piece Proximal Humeral Replacement System include noninflamatory degenerative joint disease including osteoarthritis and avascular necrosis, theumatoid arthritis, correction of severe functional deformity, revision procedures where other treatments or devices have failed, treatment of acute fractures with humeral head involvement which are unmanageable using other treatment methods and oncology applications.
The 3-Piece Proximal Humeral Replacement System is for use with bone cement.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
nanan
OFFICE 219.267.6639
FAX =
E-MAIL E =
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Summary of Technologies: The 3-piece Proximal Humeral Replacement System
Productions of indications of indications ore similar or identical to Summary of Technologies: "The 5-picce Froximal Prailers - "
components-the materials, design, sizing, and indications are similar or identical to the predicate devices.
Non-Clinical Testing: Mechanical Testing with Engineering Justifications determined Non-Clinical Testing: Mechanical Testing with Englacements presented no new
that the 3-piece Proximal Humeral Replacement to the reading e device that the 3-piece Proximal Humoral Repliceae in the predicate device.
Clinical Testing: No clinical testing was provided as a basis for substantial equivalence.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by a staff entwined with a snake, symbolizing medicine and health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2002
Ms. Dalene T. Binkley Regulatory Affairs Specialist Biomet Orthopedics, Inc P.O. Box 587 Warsaw, Indiana 46581
Re: K020045
Trade/Device Name: 3-Piece Proximal Humeral Replacement System Regulation Number: 21 CFR 888.3650 Regulation Name: Prosthesis, shoulder, non-constrained, metal/polymer cemented Regulatory Class: II Product Code: KWT Dated: December 19, 2001 Received: January 7, 2002
Dear Ms. Binkley:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 --
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and II you desire specific acvice for your do rise career, please contact the Office of Compliance at additionally 807.10 for m viro diagnosions on the promotion and advertising of your device, (301) 594-4037. Additionally, for questions of (301) 594-4639. Also, please note the cegulation prease contact the Office of Comphanee at (501) of CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small information on your responsionates ander and in 11000 638-2041 or at (301) 443-6597, or at its Manufacturers "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page of
510 (k) NUMBER (IF KNOWN): `K020045
DEVICE NAME: 3-Piece Proximal Humeral Replacement System
INDICATIONS FOR USE:
The indications for use for the 3-Piece Proximal Humeral Replacement System include The indications for use for the 3 1 rosease including osteoarthritis and avascular necrosis, nomillianalory degencrative John abouse finational deformity, revision procedures where
rheumatoid arthritis, correction of severe functional deformity, which humars' head Theumatord arthirtis, corroction of so drivent of acute fractures with humeral head other treatments of doviets nave kast, sing other treatment methods and oncology applications.
This device is for use with bone cement.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||
|---|---|---|---|
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter-Use(Optional Format 1-2-96) | |
| (Division Sign-Off)Division of General, Restorativeand Neurological Devices | |||
| 510(k) Number | K020045 |
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”